FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
43537–43560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2012
TELIO CS CEM IMPLANT
K120432 · EMA
Ivoclar Vivadent, AG
Dental · 116d
Cleared Jun 08, 2012
EARLYSENSE (EVERON) SYSTEM
K120465 · BZQ
Earlysense, Ltd.
Anesthesiology · 114d
Cleared Jun 08, 2012
MIPAL
K120470 · DRG
Watermark Medical
Cardiovascular · 113d
Cleared Jun 08, 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551 · MUJ
Simuplan S.L.
Radiology · 106d
Cleared Jun 08, 2012
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
K120624 · DRS
Elcam Medical Acal
Cardiovascular · 99d
Cleared Jun 08, 2012
AERODR STITCHING SYSTEM
K120752 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 88d
Cleared Jun 08, 2012
TUFF-TEMP 2.0
K120784 · EBG
Pulpdent Corporation
Dental · 85d
Cleared Jun 08, 2012
GMK - LINE EXTENSION
K120790 · JWH
Medacta International
Orthopedic · 85d
Cleared Jun 08, 2012
GIRAFFE BLUE SPOT PT LITE
K120820 · LBI
Lumitex, Inc.
General Hospital · 81d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · LIO
Puritan Medical Products, LLC
Microbiology · 80d
Cleared Jun 08, 2012
AMISTEM AND QUADRA - LINE EXTENSION
K121011 · LZO
Medacta International
Orthopedic · 66d
Cleared Jun 08, 2012
SCENIUM 2.0
K121074 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jun 08, 2012
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA...
K121402 · LIT
Trireme Medical, Inc.
Cardiovascular · 29d
Cleared Jun 08, 2012
PAX-FLEX3D, PHT-7000
K121412 · OAS
VATECH Co., Ltd.
Radiology · 28d
Cleared Jun 08, 2012
BELLYBOARD, SBRT ACCESSORIES
K121545 · LNH
Medtec Inc. Dba Civco Medical Solutions
Radiology · 14d
Cleared Jun 08, 2012
Q-FLO CLOSED MALE LUER CONNECTOR
K121554 · FPA
Us Fusion, LLC. Dba Truecare...
General Hospital · 14d
Cleared Jun 07, 2012
BAHADIR STERILIZATION TRAYS
K112090 · KCT
Bahadir USA Corp.
General Hospital · 322d
Cleared Jun 07, 2012
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM,...
K112607 · NKB
Spinevision S.A.
Orthopedic · 274d
Cleared Jun 07, 2012
CAPSURE(R) PS SYSTEM
K120646 · MNI
Spine Wave, Inc.
Orthopedic · 97d
Cleared Jun 07, 2012
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · QEZ
Medtronic, Inc.
Cardiovascular · 83d
Cleared Jun 07, 2012
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
K120841 · MBI
Kfx Medical
Orthopedic · 79d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · JDW
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jun 07, 2012
VIEWFLEX XTRA ICE CATHETER
K121381 · IYO
St Jude Medical
Radiology · 30d
Cleared Jun 07, 2012
FLAT PANEL DETECTOR
K121444 · OWB
Canon, Inc. - Medical Equpment Group
Radiology · 23d